CAVHANZA™ is an FDA-approved prescription medication used to treat adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase and adults with chronic and accelerated phase Ph+CML with resistance or intolerance to prior therapy, including imatinib.
CAVHANZA™ was developed by Flex Pharma and licensed for commercialization by Cycle Pharmaceuticals.
Flex’s innovative ElectroNanoSpray™ (ENS) technology provides a next-generation formulation of nilotinib that addresses the current limitations associated with TASIGNA® (and its generics). Flex developed CAVHANZA™ with the goal of improving bioavailability, lowering the delivered dose, and eliminating the large food effect observed with TASIGNA®, thereby diminishing the risk of adverse events (AEs) associated with increased exposure to nilotinib when coadministered with food. CAVHANZA™ was also formulated to be independent of the effects of gastric pH, thus enabling coadministration of acid-reducing agents (i.e., PPIs, H2RAs, and antacids). As an orally disintegrating tablet (ODT), CAVHANZA™ provides a more convenient and flexible dosage form compared to TASIGNA® (or any other presently available nilotinib product approved by FDA).
This information is not provided as advice for physicians or patients. Please refer to CAVHANZA™ official prescribing information, available at www.cavhanza.com
The ENS formulation of CAVHANZA™ can be co-administered with acid reducing agents (i.e., PPIs, H2RAs, and antacids), providing treatment options not currently available to nilotinib patients.
The ENS formulation of CAVHANZA™ can be taken with or without food—unlike TASIGNA®, which must be administered within a three-hour fasting window twice daily.
As an ODT, CAVHANZA™ can be administered as an ODT, chewed and swallowed, or swallowed intact with water, providing meaningful dosing flexibility for CML patients.
The ENS formulation of CAVHANZA™ increases the bioavailability of nilotinib, providing equivalent exposure to TASIGNA® at a 60% reduction in dose (i.e., 160 mg CAVHANZA™ versus 400 mg TASIGNA®).
PHYRAGO® is an FDA-approved prescription medication used to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) and Philadelphia chromosome-positive lymphoblastic leukemia (Ph+ALL).
Flex Pharma’s innovative ElectroNanoSpray™ (ENS) technology allows manufacturers of PHYRAGO® to provide a next-generation formulation of dasatinib that addresses the current limitations associated with SPRYCEL® (and its generics). PHYRAGO® has pH-independent absorption and is bioequivalent to SPRYCEL® at the same administered doses, thereby addressing the known limitations of SPRYCEL® while also preventing any dosing confusion for patients and physicians. PHYRAGO® is the only dasatinib therapy available that can be co-administered with acid reducing agents.
PHYRAGO® was developed by Flex Pharma and is commercialized by Cycle Pharmaceuticals.
PHYRAGO® is specifically designed to address and overcome the severe pH-dependent performance limitations associated with SPRYCEL®. Dasatinib, the active ingredient in SPRYCEL® and PHYRAGO®, is known to exhibit pH-dependent solubility. SPRYCEL® has been clinically demonstrated to provide dramatically reduced exposure when co-administered with acid reducing agents. PHYRAGO® was developed utilizing the ENS technology platform to overcome these shortcomings.
This information is not provided as advice for physicians or patients. Please refer to PHYRAGO® official prescribing information, available at www.phyrago.com
The ENS formulation of PHYRAGO® is pH-insensitive, providing more consistent drug exposures, regardless of gastric pH conditions.
The ENS formulation of PHYRAGO® can be co-administered with acid reducing agents, as demonstrated in clinical trials, providing treatment options not currently available to SPRYCEL® patients.
The ENS formulation of PHYRAGO® provides full exposure of dasatinib, even when co-administered with proton pump inhibitors and H2 blockers.